In the early days of Electronic Data Capture, the systems – which were considered revolutionary by the standards of the time – offered simple data entry screens, basic edit checks, and a sprinkling of report options. It initially changed the way trial data was captured. Today’s systems offer so much more.
Typically complex by design and long in duration, oncology trials are often difficult for sponsors and CROs to execute. This has to do primarily with the fact that these trials take more time to set up and initiate startup activities when compared to other trials, such as respiratory or diabetic.
Oncology trial data is dynamic and critical. It’s not simply crucial to the sponsor; it’s vital to the subjects involved. The real challenge stems from the very nature of the disease beimg studied – cancer is complicated, and patient profiles are even more complicated. That makes for very real challenges in Oncology Data Management.
We’ve Come a Long Way
Technology has grown dramatically, and the EDC landscape has matured alongside it. Today’s EDC essentials include easy site and user management, robust reporting options, SAE and query management, risk-based monitoring, and Source Data Verification. Additional EDC must-haves include:
- Multiple sites need to be active concurrently
- Labs must be able to enter data directly into the host system
- Medical coding should be done within the tool
- Images are required to be uploaded and properly stored
- Email, text messages and alerts must be sent to sponsors and investigators
- Availability of patient reported outcomes and diaries
Conducting a study requires big data collection that can be entered, confirmed and manipulated in a single database.
Because of EDC accessibility advancements, Oncology Data Managers (ODM) can now derive benefits from many of the tools and training which were typically the domain of database programmers.
Better Timeline Control
Oncology Data Managers are no longer dependent on outside resources when it comes to timeline control for EDC database builds. Having an ODM who can handle the build process streamlines timeline management.
Report & Query Knowledge
Because the ODM will be working with the system continually, they’re up to date and aware of potential issues with query management. Being able to anticipate these issues ensures that the database is built and maximized to mitigate potential issues.
Current Oncology Data Managers are highly dependent on EDC because of its ability to:
- Enhance communication and sharing among users
- Increase flexibility, allowing study-specific customizations
- Allow for intuitive selection of enter data and visits for end-users
- Increase the ease of query retrieval
- Make it possible for student monitors to perform and mark SDV
- Increase the efficiency of data cleaning and update ease
- Make it easy for investigators to sign off on complete CRFs
Career Development for Oncology Data Management
Because oncology data managers and their teams are responsible for all validation activity, producing error-free data for final analysis, there’s an ongoing opportunity to acquire additional technical skills and abilities. That can add an extra layer of satisfaction to oncology data management.